The following data is part of a premarket notification filed by Escalon Medical Trek with the FDA for Single Dose Gas Injector.
Device ID | K923397 |
510k Number | K923397 |
Device Name: | SINGLE DOSE GAS INJECTOR |
Classification | Calibrator, Pressure, Gas |
Applicant | ESCALON MEDICAL TREK 820 SWAN DR. Mukwonago, WI 53149 |
Contact | Ronald Hueneke |
Correspondent | Ronald Hueneke ESCALON MEDICAL TREK 820 SWAN DR. Mukwonago, WI 53149 |
Product Code | BXX |
CFR Regulation Number | 868.2620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-10 |
Decision Date | 1992-09-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10853480006157 | K923397 | 000 |